The following Background of the Invention is intended to aid the reader in understanding the invention and is not admitted to be prior art.
The detection of occult blood in stool samples is a preliminary method of detecting colon cancer. Traditional methods that detect hemoglobin in a stool sample, such as Guaiac-based chemical methods, are hampered by their inability to distinguish between dietary-derived hemoglobin (i.e. from meat in the diet) and human hemoglobin, which leads to a large number of false-positive test results. To over-come this difficulty, immunoassays specific for human hemoglobin (hHb) have been developed. The antibodies used in these assays are able to distinguish between hemoglobin derived from a human and that from another animal.
The collection and analysis of occult blood samples presents the problem of the unpleasantness of sample collection and analysis. Presently available devices fail to adequately solve these problems. Therefore, there is a clear and persistent need for a device that reduces the interaction of both the patient and the test operator with the sample while at the same time accurately detecting the presence of hHb in the sample.